Angiographic Syringe, 12 cc Thumb Ring with Rotator… recallZ-0618-05 · Hospira Inc. · initiated Nov 2, 2004
Terminated All recalls posted in March 2005
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Hospira Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Syringes could possibly allow air to enter the patient's vascular system.
FDA root cause category: Other
What the company is doing
Consignees were notified by letter on 11/10/04 or by telephone on 11/11/04.
Recall details
- Recall number
- Z-0618-05
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Nov 2, 2004
- Posted by the FDA
- Mar 15, 2005
- Recalling firm
- Hospira Inc.
- Quantity
- 8175 syringes
- Product code
- DQO
- FDA submissions
- K884823, K932188, K933700, K942329
- Distribution
- Domestic distribution: Nationwide, including 2 military/VA facilities. International distribution: Spain, Belgium, Greece, Japan, and France.
Product description
Angiographic Syringe, 12 cc Thumb Ring with Rotator Reservoir.
Code information (models, lots, serial numbers)
List Numbers: 4204201 Lot Numbers: 13193SN; 15171SN; 17151SN
Other devices under the same FDA submission
4 devices cleared under K884823, K932188, K933700, K942329 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Transpac 42587-05Icu Medical, Inc. · Catheter, continuous flush1 report
- ICU Medical 42303-02Icu Medical, Inc. · Catheter, continuous flush1 report
- ICU Medical 46056-64Icu Medical, Inc. · Catheter, continuous flush1 report
- ICU Medical 42328-66Icu Medical, Inc. · Catheter, continuous flush1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 30478).
- Z-0617-05 · TerminatedAngiographic Syringe, 10 cc Thumb Ring with Rotator Reservoir.
- Z-0619-05 · TerminatedAngiographic Syringe, 12 cc Thumb Ring with Rotator Non-Reservoir.
- Z-0620-05 · TerminatedAngiographic Syringe, 12 cc Palm Pad with Rotator Reservoir.
- Z-0621-05 · TerminatedCatheterization Kits containing Angiographic Syringes with rotator connector.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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